Catalog Number

460-10001

Brand Name

Health-Tec Cone Masks

Version/Model Number

460-10001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K020474,K020474,K020474

Product Code

MSH

Product Code Name

Respirator,Surgical

Public Device Record Key

dd2bc70d-dbd4-421d-bc56-524333386b8b

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

January 18, 2017

Package DI Number

D773460100012

Quantity per Package

10

Contains DI Package

D773460100011

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-